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临床试验/NCT00891059
NCT00891059已完成不适用

The Role Of Cognitive Impairment In The Use Of The Diskus Inhaler

Synergy Health Solutions2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
The objective is to show that mild to moderate cognitive impairment should not be a barrier to the use of Diskus Inhaler.

研究概览

简要总结

The Diskus Inhaler is administered by a nurse or medical technician in the Nursing Home (NH) setting. The administration of the medication from the Diskus Inhaler includes 4 steps: open, click, inhale, close. The only step that the resident must do is the "inhale" step, which includes holding one's breath for 10 seconds after the inhalation.

The investigators propose that properly trained and motivated nurses and medical technicians can successfully administer medication using the Advair Diskus to almost any mildly to moderately cognitively impaired resident who can follow the instruction- "inhale" and hold your breath for 10 seconds". The objective is to show that mild to moderate cognitive impairment should not be a barrier to the use of Diskus Inhaler. There will only be 1 consent visit and 1 evaluation visit per subject.

详细描述

Background and Objectives:

Approximately 1.6 million geriatric nursing home (NH) residents are living in about 17,000 Nursing Homes in the United States. This population (including those who live in Assisted Living Facilities [ALFs]) will increase significantly over the next 20 years as the "Baby Boomers" enter this age group. Associated with this will be an increasing number of cognitively impaired individuals with Chronic Obstructive Pulmonary Disease (COPD). As a nation, we will need to find effective and efficient means of caring for this growing population.

Sometimes there is an "intuitive anecdote"; a belief that mildly to moderately cognitively impaired individuals (score of 10 to 24 on the Mini Mental State Exam [MMSE]) are unable to synthesize and execute the instructions necessary for the successful use of the Diskus Inhaler for COPD. We propose a controlled assessment of DISKUS Inhaler use in mildly to moderately cognitively impaired residents living in NHs and ALFs.

The Diskus Inhaler is administered by a nurse or medical technician in the NH setting. The administration of the medication from the Diskus Inhaler includes 4 steps: open, click, inhale, close. The only step that the resident must do is the "inhale" step, which includes holding one's breath for 10 seconds after the inhalation.

We propose that properly trained and motivated nurses and medical technicians can successfully administer medication using the Advair Diskus to almost any mildly to moderately cognitively impaired resident who can follow the instruction- "inhale" and hold your breath for 10 seconds". The objective is to show that mild to moderate cognitive impairment should not be a barrier to the use of Diskus Inhaler.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult men and women residing in a NH or ALF
  • Mini Mental Status Exam (MMSE) score between 10 and 24 inclusive
  • Able to hold breath for at least 10 seconds
  • Able to speak and understand English

排除标准

  • Current or history of Diskus use

结局指标

主要结局

The objective is to show that mild to moderate cognitive impairment should not be a barrier to the use of Diskus Inhaler.

时间窗: Immediate

次要结局

未报告次要终点

研究者

发起方
Synergy Health Solutions
申办方类型
Other

研究点 (2)

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